Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine

NCT ID: NCT00626743

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-07-31

Brief Summary

To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SK3530

Active Drug

Group Type: EXPERIMENTAL

SK3530 100mg, Placebo, Amlodipine

Intervention Type: DRUG

Placebo

Tablet which has the same appearance and taste but doesn't contain active ingredient

Group Type: PLACEBO_COMPARATOR

SK3530 100mg, Placebo, Amlodipine

Intervention Type: DRUG

Interventions

SK3530 100mg, Placebo, Amlodipine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male subjects 19-65 years of age inclusive
• Subjects with hypertension as defined 100 mmHg ≤ SBP<140 mmHg and 65 mmHg ≤ DBP < 90 mmHg after more than 5 minutes in the supine position
• Written informed consent
• Willing and able to comply with the requirements of the protocol

Exclusion Criteria

• Subjects with acute or chronic disease within 4 weeks of study initiation.
• Subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.)
• Subjects with any clinically significant allergic disease or with a known allergy to the PDE5 inhibitors
• Subjects with clinically significant abnormalities on laboratory tests
• Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes a standing position
• Subjects with abnormal QTc interval(≥440ms)
• Subjects with color-blindness or weakness
• Subejcts with alcohol, drug or caffeine abuse
• Diet known to alter drug absorption, distribution, metabolism or elimination processes
• Subjects who participated in other clinical studies within 2 months before an administration
• Other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Gook Shin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

INJE University Pusan Paik Hospital

Pusan, , South Korea

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SK3530_AMD_I_2007

Identifier Type: -

Identifier Source: org_study_id